Pet Recall Facts

Ingredients / Medetomidine

Medetomidine: FDA adverse event reports for pets

Reports received through June 26, 2026. Data and limitations.

3,197Total reports
2,645Dog reports
468Cat reports

FDA-approved products with this ingredient (Green Book)

All approved products with this ingredient, for any species.

Brand names come only from the Green Book. Brand names in FDA's public report data are masked, so counts cannot be attributed to any brand. Ingredient names in the reports are written many ways; we group them under one ingredient name and count each report once per ingredient (method).

Reports by year received

199619
1997338
1998297
1999215
2000229
2001165
2002148
2003110
2004182
2005184
2006211
2007174
2008197
200938
20108
20112
20123
20136
20144
20153
20163
20172
20183
20193
20201
20213
202285
2023215
2024161
2025133
202654

Species named in reports

Dog2,645
Cat468
Human23
Not given22
Other11
Monkey5
Rabbit4
Rat3

Signs reported after Medetomidine

INEFFECTIVE, SEDATION687
Death491
Lack of efficacy - NOS312
Sedation prolonged246
Vomiting217
Bradycardia197
Cardiac arrest189
Apnoea161
Depression147
Convulsion142
Anorexia137
Labelled drug-drug interaction medication error122
Diarrhoea115
Hypersalivation92
Fever91
Lung oedema86
Tachycardia84
Death by euthanasia83
Cyanosis81
Elevated alanine aminotransferase (ALT)81
Dyspnoea80
Ataxia77
Vocalisation73
Elevated serum alkaline phosphatase (SAP)70
Recovery prolonged70

Breeds named in reports

Dog (unknown)498
Crossbred Canine/dog347
Domestic (unspecified)270
Retriever - Labrador244
Rottweiler134
Shepherd Dog - German132
Cat (unknown)97
Retriever - Golden96
Mixed (Dog)91
Chow Chow61
Poodle (unspecified)52
Boxer (German Boxer)50
Spaniel - Cocker American46
Chihuahua45
Shih Tzu38

Reported outcomes

Died563
Recovered/Normal509
Outcome Unknown110
Euthanized33
Ongoing32
Recovered with Sequela1

Report a problem to FDA